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RecruitingInterventionalPhase 4

Evaluation of Revaree Plus in Women With Breast Cancer

NCT ID: NCT07042581Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-02-06

Summary

The purpose of this study is to find out whether Revaree Plus is effective at improving vaginal health for people who are having symptoms of vaginal dryness during breast cancer treatment.

Arms & interventions

  • DrugRevaree Plus

    Revaree Plus is a hyaluronic acid vaginal suppository

Outcome measures

Primary

  • Change in Vaginal Assessment Scale from baseline to 8 weeks

    The primary study objective is to evaluate whether vaginal health improves from baseline to 8 weeks of treatment with Revaree Plus as measured by the Vaginal Assessment Scale

    Time frame: 8 weeks

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * ≥18 years of age at the time of signing informed consent. * Stage 0-3 hormone-receptor positive breast cancer confirmed at MSKCC * Able to complete study questionnaires in English or Spanish * Breast cancer patients must have completed primary therapy (surgery, and/or chemotherapy, and/or radiation therapy) or currently on maintenance therapy * Currently on an aromatase inhibitor or tamoxifen or Selective Estrogen Receptor Modulators (SERM) * Currently have no clinical evidence of disease * Reporting being bothered by vaginal symptoms of estrogen deprivation (i.e., vaginal dryness, dyspareunia, or discomfort \[pain with intercourse or examination\]) * A total score of 4 or greater in VAS * Without history of other cancers (excluding non-melanoma skin cancer) * Must sign an informed consent indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study Exclusion Criteria: * Inability to provide informed consent * Vaginal bleeding of unknown etiology within 12 months of study entry * Currently taking hormone replacement therapy \[local or systemic\] (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment) * Existing use of external estrogens or nonhormonal moisturizers (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment) * No known allergies to any ingredients in 10mg HLA suppository

Study locations (7)

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, 07920

Recruiting
Shari Goldfarb, MD · Contact

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, 07748

Recruiting
Shari Goldfarb, MD · Contact

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, 07645

Recruiting
Shari Goldfarb, MD · Contact

Memorial Sloan Kettering Cancer Center Suffolk-Commack (Consent Only)

Commack, New York, 11725

Recruiting
Shari Goldfarb, MD · Contact

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, 10604

Recruiting
Shari Goldfarb, MD · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

Recruiting
Shari Goldfarb, MD · Contact

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, 11553

Recruiting
Shari Goldfarb, MD · Contact